Trial Information

OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal
cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the
toxicity profile of this regimen in this patient population. III. Compare response rates
obtained in this study with those observed in recent phase III studies in younger patients.

OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every
8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or
disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 75 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST or ALT no greater
than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN
Other: No serious infection No other serious underlying medical condition that would
preclude protocol therapy No known hypersensitivity to fluorouracil-uracil or leucovorin
calcium

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